Fortidose

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fortidose 1% and 2% prolonged-release eye drops,

in single-dose containers
Carteolol hydrochloride
Please read this leaflet carefully before using this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Fortidose is and what it is used for
2. What you need to know before using Fortidose
3. How to use Fortidose
4. Possible side effects
5. How to store Fortidose
6. Contents of the pack and other information

1. WHAT FORTIDOSE IS AND WHAT IT IS USED FOR

Fortidose belongs to a class of medicines called beta-blockers.
It is used for the local treatment of the following eye conditions:

• a certain type of glaucoma (chronic open-angle glaucoma),
• increased pressure in the eye(s) (intraocular hypertension).

2. WHAT YOU NEED TO KNOW BEFORE USING FORTIDOSE

Do not use Fortidose:

• if you are allergic (hypersensitive) to carteolol hydrochloride or to any of the excipients in Fortidose;
• if you currently have or have previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing and/or long-lasting cough);
• if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeats);
• if you suffer from bradycardia (slower than normal heart rate, for example less than 40–45 beats per minute);
• if you have untreated pheochromocytoma (excessive production of a hormone causing severe arterial hypertension).

Warnings and precautions
Talk to your doctor or pharmacist before using Fortidose
if you currently have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure;
• cardiac conduction disorders, such as reduced heart rate;
• respiratory problems, asthma or chronic obstructive pulmonary disease (a lung disease that may cause wheezing, difficulty breathing and/or long-lasting cough);
• diseases related to poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome);
• diabetes, since carteolol may mask signs and symptoms associated with low blood sugar levels;
• overactive thyroid gland, as carteolol may mask its signs and symptoms;
• treated pheochromocytoma;
• psoriasis;
• corneal disease;
• history of allergic reactions;
• kidney or liver disease.

Before undergoing surgical anesthesia, inform your doctor that you are using Fortidose,
as carteolol may alter some effects of medicines used during
anesthesia.
When using this medicine, you should undergo regular eye examinations,
starting at the beginning of treatment and continuing thereafter, approximately every 4
weeks, to monitor whether you are developing resistance to the therapeutic
effect of the product. Additionally, with long-term treatment, certain tests may be needed to detect possible treatment failure (loss of effectiveness of the medicine).
If you wear contact lenses: this class of medicines may reduce tear production and therefore increase the risk of intolerance to contact lenses.
The active ingredient contained in this medicine may cause positive results in anti-doping tests.
This eye drop must not be used in neonates or premature infants, children or
adolescents.
Other medicines and FORTIDOSE
Inform your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines.
Fortidose may interact with or be affected by other medicines, including other eye drops used for glaucoma treatment.

• If you are using other eye medications, you must:
• instill the other ophthalmic medicine first,
• wait 15 minutes,
• then instill Fortidose last.
• For the treatment of certain types of glaucoma (such as closed-angle glaucoma), your doctor may also prescribe miotic eye drops.
• If you use adrenaline/epinephrine eye drops at the same time as Fortidose, ophthalmological monitoring is required (due to the risk of pupil dilation).
• If you are taking oral beta-blockers concurrently, a dose adjustment of Fortidose may be necessary.

Even though the amount of beta-blockers reaching the bloodstream after
application into the eye(s) is low, keep in mind the possibility of interactions
with oral beta-blockers:

• concomitant use of amiodarone (used to treat heart rhythm disorders), certain calcium antagonists (used to treat hypertension, such as bepridil, verapamil, diltiazem) or other beta-blockers (used to treat heart attack) is not recommended.
• increased blood levels of lidocaine may occur, which could increase the risk of adverse cardiac and neurological events.

Inform your doctor if you are taking or intend to take medicines to lower blood
pressure, heart medications, or medicines to treat diabetes or multiple sclerosis.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription: specific monitoring may be required if necessary.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Fortidose must not be used during pregnancy unless your doctor considers it necessary.
There are insufficient data on the use of carteolol hydrochloride during pregnancy. Carteolol hydrochloride should not be used during pregnancy unless clearly necessary.
To reduce systemic absorption, see section 3.
Breastfeeding
Do not use Fortidose if you are breastfeeding, as carteolol hydrochloride may pass into breast milk.
Consult your doctor before taking any medicine during
breastfeeding.
Beta-blockers are excreted in breast milk. However, at therapeutic doses of carteolol hydrochloride eye drops, the amount excreted into breast milk is not sufficient to cause beta-blockade symptoms in infants. To reduce systemic absorption, see section 3.
Driving and use of machines
Blurred vision may occur after applying this medicine to the eye(s).
Do not drive or operate machinery until your vision returns to normal.

3. HOW TO USE FORTIDOSE

This medicinal product is for ophthalmic use (in the eye[s]).
Always use this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Dosage
Fortidose contains a specific excipient with physical properties that allow for
once-daily administration.
The usual dose is one drop in the affected eye[s] once daily, in the morning.
However, your doctor may decide to adjust the dosage, especially if you are
already taking oral beta-blockers (by mouth) (see section 2 “Other medicines and
Fortidose”).
Method and route of administration

• If you wear contact lenses, you must remove them before instilling Fortidose and wait 15 minutes before reinserting them.
• For correct administration of Fortidose:
• wash your hands thoroughly before using the product,
• before each new instillation, remove a single-dose container from the strip,
• twist the tip of the single-dose container to open it. Invert the single-dose container: gently squeeze the container to allow the eye drops to pass through the opening,
• avoid touching the eye or eyelids with the tip of the dispenser,
• instill one drop into the eye[s] by looking upward and gently pulling down the lower eyelid,
• after administration, keep the eye[s] closed for a few seconds,
• after using Fortidose, press with one finger at the inner corner of the eye, near the nose, for 2 minutes. This helps prevent carteolol from reaching the rest of the body.
• with the eye[s] closed, wipe away any excess product,
• discard the single-dose container immediately after use,
• do not reuse a single-dose container that has already been opened and/or used,
• the amount of eye drops contained in a single-dose container is sufficient for treatment of both eyes.
• If you are using any other eye medication, refer to section 2 “Use with other medicines”.
• If your doctor has prescribed Fortidose as a replacement for another medicine, use of the other eye drops should be discontinued after appropriate daily administration. You may start treatment with Fortidose the following day, at the dosage prescribed by your doctor.
• If you feel that Fortidose is having too much or too little effect, inform your doctor or pharmacist.

Do not inject, do not swallow.
Duration of treatment
Follow your doctor’s instructions. He/she will tell you how long you should use Fortidose.
Do not stop treatment earlier than indicated by your doctor.
If you use more Fortidose than you should
If you accidentally apply more drops than necessary into the eyes, rinse the eyes with
plenty of running water.
If you accidentally swallow the contents of the bottle, adverse events such as mild
mental confusion, breathing difficulties, or a sensation of slowed heartbeat may occur.
In such cases, contact your doctor or pharmacist immediately.
If you forget to use Fortidose
Do not take a double dose to make up for the missed dose.
If you stop using Fortidose
If you stop treatment, the pressure in your eyes may rise and lead to worsening of
vision.
Never stop treatment without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, contact your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
You can usually continue using the drops unless the side effects are severe. If you are
concerned, consult your doctor or pharmacist. Do not stop using Fortidose without
consulting your doctor.
Like other ophthalmic medicines applied to the eye (topical ophthalmic drugs),
carteolol hydrochloride may be absorbed into the bloodstream. This may cause side
effects similar to those observed with systemic beta-blockers. The frequency of adverse
events after topical ocular administration is lower than when medicines are taken, for
example, by mouth or by injection. The list of adverse events includes reactions
observed in the class of ophthalmic beta-blockers.
The frequency of the following adverse events is common (may affect up to 1 in
10 users):

• Signs and symptoms of eye irritation (e.g. burning, stinging sensation, itching, tearing and redness), conjunctival redness, conjunctivitis, eye irritation or sensation of having something in the eye (keratitis).
• Taste disturbances.

The frequency of the following adverse events is uncommon (may affect up to 1 in
100 users):

• Dizziness
• Muscle weakness or pain not caused by exercise (myalgia), muscle cramps.

The frequency of the following adverse events is rare (may affect up to 1 in
1000 users):

• Positive antinuclear antibody test results.

In very rare cases, some patients with severe damage to the transparent front part of
the eye (cornea) have developed during treatment, opaque spots on the cornea due to
calcium deposits.
The frequency of the following adverse events is not known (frequency cannot be
estimated from the available data):

• Allergic reactions, including sudden swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, urticaria, localized and generalized skin rash, itching, life-threatening sudden allergic reactions.
• Low blood sugar levels.
• Difficulty falling asleep (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood flow in certain areas of the brain, worsening of signs and symptoms of myasthenia gravis (muscle problems), tingling or numbness of hands and feet, tingling, headache.
• Swollen eyelid (blepharitis), blurred vision and low eye pressure, visual disturbances following surgery (choroidal detachment after filtering surgery), decreased corneal sensitivity, dry eye, damage to the anterior membrane of the eye (corneal erosion), drooping of the upper or lower eyelid, double vision, changes in refraction (sometimes due to discontinuation of treatment with miotic eye drops).
• Slow heartbeat, chest pain, palpitations, increased fluid retention (edema), changes in heart rhythm and rate, heart conditions causing shortness of breath and swelling of feet and legs due to fluid accumulation (congestive heart failure), atrioventricular block, heart attack, heart failure, leg cramps and/or leg pain when walking (claudication).
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Bronchospasm (wheezing or breathing difficulties – usually in patients with pre-existing bronchospastic disease), shortness of breath (dyspnea), cough.
• Nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with silver-coloured patches (psoriasiform erythema), or worsening of psoriasis, skin rash.
• Systemic lupus erythematosus.
• Sexual dysfunction, decreased libido.
• Unusual muscle weakness or pain not caused by physical exercise (asthenia) or fatigue.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. HOW TO STORE FORTIDOSE

• Do not use Fortidose ophthalmic solution, prolonged release, in single-dose containers after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Discard the single-dose container immediately after opening.
• Do not use the product if the seal is damaged.
• Keep this medicine out of the sight and reach of children.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Fortidose contains:

• Active substance: Carteolol hydrochloride ………… ………… …..1 g per 100 ml of Fortidose 1% or a single-dose container (0.2 ml) contains 2 mg of carteolol hydrochloride
  Carteolol hydrochloride ………… ………… …..2 g per 100 ml of Fortidose 2% or a single-dose container (0.2 ml) contains 4 mg of carteolol hydrochloride

Excipients: disodium hydrogen phosphate dihydrate, sodium phosphate dodecahydrate, sodium chloride, alginic acid, sodium hydroxide (pH regulator), purified water.

Description of the appearance of Fortidose and pack contents
The medicinal product is a prolonged-action eye drop solution, packaged in strips of single-dose containers of 0.2 ml, sealed in pouches (Polyester/Aluminum/Polyethylene). Boxes containing 5 or 30 single-dose containers.
The solution is clear and slightly yellowish-brown.

Marketing Authorization Holder
Bausch & Lomb-IOM S.p.A.
Via Pasubio, 34
20846 Macherio (MB), Italy

Manufacturer
Laboratoire CHAUVIN – Zone Industrielle Ripotier Haut – 07200 Aubenas - France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Carteol LP 1% & 2% collyre en solution à libération prolongée en récipient unidose
Portugal: Physioglau 1% & 2% UD, colírio de libertação prolongada, recipiente para dose única
Italy: Fortidose 1% e 2% collirio a rilascio prolungato, in contenitori monodose
Spain: Arteoptic 10 mg/ml y 20 mg/ml unidosis, colirio de liberación prolongada, en envase unidosis